Solid dispersions

Amorphous solid dispersions increase API solubility through elimination of the impact of crystal lattice energy on the dissolution process. The physical stabilisation of the amorphous state of the API ingredient is accomplished via dispersion in a polymer matrix. The identification of a polymer with sufficient solid-state miscibility with the API is key to the suppression of API recrystallisation and to ensuring consistent performance over time. We identify suitable carrier polymers via a combined approach of precipitation assays and solvent evaporation trials, both conducted at milligram scale. Formulation concepts with adequate performance and physical stability are subsequently scaled-up and GMP-produced via either spray-drying or bead-layering.